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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 4.0MM X 25MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 4.0MM X 25MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number M003111FPP0
Device Problems Fracture (1260); Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/20/2020
Event Type  malfunction  
Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release. Visual inspection revealed the proximal end of the stabilizer was kinked, the proximal of the delivery catheter was deformed. Additionally, the stent was partially deployed, and the distal end of the delivery catheter was broken/damaged with the braid wire exposed and the ro (radiopaque) marker band missing. Following the functional test ,the delivery catheter was flushed, and the stabilizer was advanced to deploy the stent, the distal end of the stabilizer was broken/fractured at 6cm from the distal end. The deployed stent was deformed at both ends and the stabilizer was unable to be removed from the catheter due to the damage noted. The reported event is covered in the device directions for use (dfu). As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event. As per the additional information there was a sharp curve in the carotid. The device was returned and the damage noted to the device is indicative of the reported event. It is probable that the device was damaged during navigation to the target vessel, causing the reported and analysed defects. An assignable cause of procedural factors will be assigned to the reported event and to the analysed , as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
 
Event Description
Analysis of the returned device revealed that the subject stent stabilizer broken/fractured during use, and the ro (radiopaque) marker band was missing. There were no clinical consequence to the patient reported as a result of this event. Additional information received on 10/24/2020 indicated that there were no markers in the patient. That there were markers at the beginning of the procedure and it was possible to visualize them until the moment of stent removal. In addition, he stressed that the defect / reason for the subject stent not progressing was a loose wire. The images of the patient's angiography, and also a video were made on a table with the streamline already outside the patient, where it shows on the markers on the stent.
 
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Brand NameSURPASS STREAMLINE 4.0MM X 25MM - CE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key10596794
MDR Text Key209455124
Report Number3008881809-2020-00278
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
P170024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 09/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/16/2021
Device Catalogue NumberM003111FPP0
Device Lot Number20474883
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/18/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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